What you'll do:

Demonstrates technical proficiency, cross-functional collaboration with External Manufacturing, Process Development, Analytical Development, Quality Control, and other relevant stakeholders to drive improvement, consistency and compliance for drug product manufacturing processes.
Establish internal Drug Product Development capabilities including:

Design and conduct experiments to develop stable and effective drug formulations, including selection of excipients, and compatibility studies.
Conduct stability studies to assess the short- and long-term integrity of drug products under various storage conditions and identify potential degradation pathways.
Establish and qualify representative scale down models in support of drug product process design.
Design drug product process characterization (PC) strategies, engage cross-functional SMEs and execute PC activities to enable BLA submission.
Develop and scale-up manufacturing processes considering critical process parameters (CPPs) and critical quality attributes (CQAs). Utilize statistical analysis and experimental design to identify and improve process parameters, maximizing product yield and quality consistency.
Provide support for drug product process technology transfer and GMP manufacturing at CDMOs, review GMP documents, troubleshoot technical issues, support deviation investigation, lead risk assessment and serve as person-in-plant as required.
Manage, collaborate and provide scientific oversight of formulation and drug product process development and data generated by internal and contract labs.
Must think critically, ability to work independently and awareness on when to seek guidance and have strong organizational and planning skills.
Author and review technical development documents including study protocols, technical reports, and batch records.
Provide direction and leadership to junior scientists.

About you:

Ph.D. in Pharmaceutical Chemistry, Biochemistry, Chemistry, Chemical Engineering, Bioengineering or related discipline with 5-8 years of relevant experience in biologics or viral vector drug product development; or M.S. with 8-11 years of relevant experience. Job title is dependent on candidate’s experience level.
Must have proven experience with formulation development, drug product process development and optimization, statistical design and analysis of experiment, managing CROs, tech transfer to CDMOs.
Must have knowledge and hands-on experience with analytical instrumentation used in biologics/viral vector formulation and process development such as spectrometry, HPLC, CE, particle characterization techniques, calorimetry, light scattering etc.
Experience with fill-finish processes, clinical compatibility studies, scale-up and/or technology transfer.
Experience with unit operation (i.e. filling, filtration, mixing, etc.) specific scale down model development, characterization, and scale-up.
Knowledge of regulatory requirements and quality standards related to biopharmaceutical manufacturing.
Must have excellent problem-solving skills, verbal and written communication skills.
Ability to work in a dynamic environment, with a willingness to adapt to shifting priorities and tasks.
Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
Ability to work independently in a fast-paced startup environment as well as work collaboratively in a highly interactive team environment.

Senior Scientist, Drug Product (Contract)

TLDR